The intended use of the Al6 is the measurement of arterial blood flow by means of venous occlusion plethysmography. The Al6 replaces the predicate instruments which are used primarily in research studies. Applications include studies that relate to protocols that influence limb blood flow through exercise, reactive hyperemia, or the influence of drugs.

The intended use of the Al6 is the measurement of blood flow by means of venous occlusion plethysmography. This is the same usage as one of the uses of our EC6 Plethysmograph and it has not changed.

Device Description

The Al6 Blood Flow Measuring system measures blood flow in one or two limbs or digits simultaneously using the principles of venous occlusion plethysmography. This involves inflating a blood pressure cuff on the proximal part of the limb to a pressure that exceeds the venous pressure in the limb, but which is less than the arterial pressure. The cuff inflation is done quickly so as to obtain a distinct starting point for the measurement. When the cuff is inflated the limb begins to swell due to the blood flowing into the limb since the normal venous outflow is stopped by the cuff. The resulting change in the volume of the limb is measured by the plethysmographs and the rate of change is equal to the blood flow at the moment of venous occlusion. The Al6 is controlled by a computer program that causes the cuff inflators to inflate, records the plethysmographic volume measurements and calculates the rate of change of volume. By combining the instruments and controlling them with one computer it is possible to make measurements in quick succession and more easily analyze the results.

AI/ML Overview

The provided documentation describes the Hokanson Blood Flow Measuring System (AI6), but it does not contain a typical acceptance criteria table with reported device performance metrics against specific thresholds. Instead, the submission focuses on demonstrating equivalence to predicate devices through comparisons of key components and their performance.

Here's a breakdown of the requested information based on the provided text, highlighting where information is present and where it is absent:

1. Table of acceptance criteria and the reported device performance

As mentioned, a formal table of acceptance criteria with specific performance metrics and their corresponding thresholds is not present in the provided document. The submission assesses performance relative to predicate devices.

Feature Assessed	Predicate Device Comparison	Reported AI6 Performance
Accuracy of Strain Gauge Plethysmographs	Same technology and strain gauges as predicate device (EC6 Plethysmograph, K982707).	"equal to the EC6 predicate device."
Accuracy of Pressure Regulators	Same pressure regulator as predicate device.	"identical to that of the predicate device."
Pressure Accuracy (Venous Occlusion Cuff)	Not explicitly compared as a separate predicate characteristic, but the predicate device also performs venous occlusion plethysmography.	"within plus or minus 1 mmHg." (Note: requirement for venous occlusion pressure is 15-100 mmHg; 50-60 mmHg usually chosen)
Speed of Inflation	Tubing identical to predicate device (E20, K905367). Valves have slightly higher Cv than predicate device.	"equal to that of the predicate device." Largest cuff inflates from 0 to 50 mmHg in less than 300 mSec, which is less than one heartbeat.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission describes bench testing and comparisons to predicate devices, not studies involving human subjects or specific data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The evaluation described is based on engineering and performance characteristics of components, not on expert-adjudicated ground truth from a test set of medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. There is no mention of a test set requiring adjudication in the context of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A MRMC study was not conducted. This device is a measurement system and does not involve AI assistance for human readers or interpretation of medical images.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is a physical medical device (Blood Flow Measuring System) that performs measurements. While it is computer-controlled, it's not an "algorithm only" device in the sense of an AI diagnostic tool. The description focuses on its standalone measurement capabilities as equal to combined predicate devices. Therefore, the functional performance of the device itself can be considered standalone, but it's not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission is based on physical constants, engineering specifications, and the established performance of the predicate devices. For example, pressure accuracy is measured against a known standard (mmHg), and inflation speed is measured against a known time (mSec). The core claim is that since the components and their performance are equivalent to legally marketed predicate devices, the new device is also safe and effective.

8. The sample size for the training set

This information is not applicable/provided. This device does not use machine learning or AI algorithms that require a "training set."

9. How the ground truth for the training set was established

This information is not applicable/provided as there is no training set for an AI algorithm.

Summary

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Supplemental Information for AI6 Blood Flow Measurement System, K023707

K023707
page 1 of 2

510(k) Summary

Date prepared:

December 16, 2002

Submitter's Information

Company Name Establishment Registration Number Street Address City, State, Zip, Country Telephone FAX Contact Person Title E-mail

D. E. Hokanson, Inc 3019130 12840 NE 21st Place Bellevue, WA 98040, USA (425) 882-1689 (425) 881-1636 D. Eugene Hokanson President gene@deh-inc.com

FEB 1 2 2003

Item 6

Trade Name, Common Name, Classification

Trade Name: Hokanson Blood Flow Measuring System Common Name Venous Occlusion Flow Measuring System Classification Name Strain Gauge Plethysmograph System Device Class Class II Product Code Ale

Identification of Predicate Device(s)

The Al6 combines elements and functions of the following devices:

Device	Manufacturer	510(k)
Strain GaugePlethysmograph	Hokanson	K982707
Rapid Cuff Inflator	Hokanson	K905367
ECG Trigger	Hokanson	K973426
Deltran 1 PressureTransducer	Utah Medical	K841788/C
NIVP3 Computer Program	Hokanson	K932852

Description of the Device

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510(k) Summary Continued

Intended Use

Non-clinical tests showing equivalence.

The accuracy of venous occlusion plethysmographic measurements depends primarily on two things. One is the calibration and accuracy of the strain gauge plethysmograph and the other is the speed and pressure control of the venous occlusion cuffs.

The accuracy of the strain gauge plethysmographs is the same as that of the predicate device by using the same technology and by employing the same strain gauges. The results of mechanical calibration tests show the Al6 to be equal to the EC6 predicate device.

The accuracy of the pressure requlators is identical to that of the predicate device since the same pressure regulator is used. Although the exact pressure is not very critical in venous occlusion plethysmography, the pressure setting is actually improved in the new device since the pressure is controlled by the computer in a closed-loop system whereas the predicate device is set manually. The requirement is that the pressure in the venous occlusion cuff should be above venous pressure and below arterial pressure, i.e. somewhere between 15 and 100 mmHg. Usually a venous occlusion pressure of 50 to 60 mmHg is chosen in practice. The pressure accuracy of the Al6 is within plus or minus 1 mmHg.

The speed of inflation is controlled by the size of the valves and tubing that connect to the cuff. The tubing used in the Al6 is identical to that used in the E20 predicate device. The valves have a slightly higher Cv than those in the predicate device. The inflation rate measured by inflating a test object is equal to that of the predicate device. Our largest blood pressure cuff can be inflated by the Al6 from 0 to 50 mmHg in less than 300 mSec. In order to show a distinct starting point for a measurement it is desirable to inflate the venous occlusion cuff in less than one heart beat.

The conclusions to be drawn from these tests are that the Al6 is equal to the predicate devices in accuracy and safety.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is facing to the left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2003

D.E. Hokanson, Inc. c/o Mr. D. Eugene Hokanson President 12840 NE 21st Place Bellevue. WA 98005

Re: K023707

Trade Name: Hokanson Blood Flow Measuring System Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic, or photoelectric plethysmographs Regulatory Class: Class II (two) Product Code: JOM Dated: January 27, 2003 Received: February 4, 2003

Dear Mr. Hokanson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. D. Eugene Hokanson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Olia Mallis

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Supplemental Information for A16 Blood Flow Measurement System, K023707

Intended Use Statement (modified)

The intended use of the Al6 is the measurement of blood flow by means of venous occlusion plethysmography. This is the same usage as one of the uses of our EC6 Plethysmograph and it has not changed.

Omallis

ivision of Cardiovascular Devices

510(k) Number K023707

Prescription Use X
(Per 21 CFR 801.109)

ltem 1

Regulation Number and Section

§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).